Disclaimer: This document is a compilation of definitions from many sources within EPA and outside of EPA. This compilation is for informational purposes only. No inference should be drawn by the inclusion or exclusion in this document of any term or definition. These definitions and any associated commentary are not binding and have no legal effect as a result of their inclusion in this document; they do not constitute an EPA statute or regulation and do not substitute for such authorities. In addition, the compilation of definitions and associated commentary in this document have not been reviewed or endorsed by Agency management, and thus do not constitute official statements of EPA’s views and are not binding on EPA or any party.

5.1 General and Framework Terms

agent

Any physical, chemical, or biological entity that can induce an adverse response (synonymous with stressor). (EPA 1998b)

A chemical, physical, or biological entity that may cause deleterious, beneficial, or no effects to an organism after the organism is exposed to it. (EPA 2004)

The term “agent” refers generally to any chemical substance, mixture, or physical or biological entity being assessed, unless otherwise noted. (EPA 2005a)

Any physical, chemical, or biological entity that can be harmful to an organism. (EPA 2005b)

A factor, such as a microorganism, chemical substance, or form of radiation, whose presence, excessive presence, or (in deficiency diseases) relative absence is essential for the occurrence of a disease. (CDC 2005)

analysis

The systematic application of specific theories and methods, including those from natural science, social science, engineering, decision science, logic, mathematics, and law, for the purpose of collecting and interpreting data and drawing conclusions about phenomena. It may be qualitative or quantitative. Its competence is typically judged by criteria developed within the fields of expertise from which the theories and methods come. (EPA 2004)

Detailed examination of anything complex, made in order to understand its nature or to determine its essential features. (IPCS/OECD 2004)

This term in used in conjunction with many other words to create multiword terms that have specific unique meanings (e.g. risk analysis, analysis plan, analysis phase).

analysis phase

A component of microbial risk assessment consisting of the technical evaluation of data concerning potential exposure and associated health effects. Elements of this process are characterization of exposure and characterization of human health effects. (ILSI 2000)

analysis plan

A plan that provides all the details of exactly how each part of the risk assessment will be performed. It usually describes in detail what analyses will be performed, how they will be performed, who will perform the work, schedules, resources, quality assurance/quality control requirements, and documentation requirements. (EPA 2004)

anecdotal data

Data based on the description of individual cases rather than controlled studies. (EPA 2003)
RELATED TERMS: anecdotal evidence, case studyAdditionally, anecdotal data may lack quantitative specifics and can come from sources that are not peer reviewed such as the popular media. In the epidemiology context, anecdotal data refers specifically to case studies, but other disciplines use the term to refer to pieces of information that are based on casual observations rather than rigorous or scientific analysis.

anecdotal evidence

animal studies

Toxicity investigations using animals. Such studies may employ animals as surrogates for humans with the expectation that the results are pertinent to humans or for investigation of effects pertinent to animals (e.g., for ecological risk assessment). (EPA 2004, EPA 2005b)

anthropogenic

Of human origin. (RAIS 2004, SRA 2004)

assessment

Evaluation or appraisal of an analysis of facts and the inference of possible consequences concerning a particular object or process. (IPCS/OECD 2004)

assessment endpoint

An explicit expression of the environmental value to be protected. An assessment endpoint includes both an ecological entity and specific attributes of that entity. For example, salmon are a valued ecological entity; reproduction and population maintenance (i.e., the attribute) form an assessment endpoint. (EPA 2004)

Qualitative/quantitative expression of a specific factor with which a risk may be associated as determined through an appropriate risk assessment. (IPCS/OECD 2004)

assessment factor

Numerical adjustment used to extrapolate from experimentally determined (dose-response) relationships to estimate the agent exposure below which an adverse effect is not likely to occur. (IPCS/OECD 2004)
RELATED TERMS: safety factor, uncertainty factor

assessment questions

The questions asked during the planning/scoping phase of the risk assessment process to determine what the risk assessment will evaluate. (EPA 2004)

assumption

The thing supposed; a postulate, or proposition assumed; a supposition. (CancerWEB 2005)

attributable proportion

A measure of the public health impact of a causative factor; proportion of a disease in a group that is exposed to a particular factor which can be attributed to their exposure to that factor. (CDC 2005)

best management practice (ACRONYM: BMP)

Methods that have been determined to be the most effective, practical means of preventing or reducing pollution from non-point sources. (EPA 2005b)

best professional judgment

Utilizing knowledge based on education and experience to determine the best course of action during the course of performing a risk assessment project. (EPA 2004)
RELATED TERMS:expert judgment

biologically plausible

Biologically plausible is associated with guidelines (sometimes referred to as the Bradford Hill criteria) for causal inference from epidemiological evidence. In that context, an assessment of the biological plausibility of an association demonstrated by epidemiological analysis is meant to ensure that such an association is consistent with current biological knowledge. Evidence regarding biological plausibility can never prove causality. Therefore, it is also meant to guard against attributions of causality to biologically implausible statistical associations that might result from studies that have not adequately accounted for important variables. (IOM 2002)

Can refer to both epidemiological analysis as well as theoretical biological mechanisms.

causality

The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors. (CancerWEB 2005)

ceteris paribus

Latin for “other things equal.” Ceteris paribus clauses are nonstrict generalizations but generalizations that hold when other things are equal. They typically occur conjoined with incomplete descriptions of the factors whose presence or absence bring about an outcome. (Floridi 2003)

characterization of exposure

A portion of the analysis phase of ecological risk assessment that evaluates the interaction of the stressor with one or more ecological entities. Exposure can be expressed as co-occurrence or contact, depending on the stressor and ecological component involved. (EPA 1998b)

A component of the analysis phase of microbial risk assessment that evaluates any interactions between the pathogen, the environment, and the human population. Steps in this process are pathogen characterization, determination of pathogen occurrence, and exposure analysis; the result is an exposure profile. (ILSI 2000)

characterization of human health effects

A component of the analysis phase of microbial risk assessment that evaluates the ability of a pathogenic microorganism to cause adverse human health effects under a particular set of conditions. Steps in this process are host characterization, evaluation of human health effects, and quantification of the dose-response relationship; the result is a host-pathogen profile. (ILSI 2000)

community

The persons associated with an area who may be directly affected by area pollution because they currently live in or near the area, or have lived in or near the area in the past (i.e., current or past residents), members of local action groups, local officials, tribal governments, health professionals, and local media. Other entities, such as local industry, may also consider themselves part of the community. (EPA 2004)Note: there are a number of other definitions of community that are especially used in ecology and human social sciences, as well as in describing microbiological relationships but they were not apparent in the documents examined in this effort.

comparative risk assessment

The process of comparing and ranking various types of risks to identify priorities and influence resource allocations. (EPA 2004)

Comparative risks can be among different pathogens and different exposures. Common metrics would provide a basis for such comparisons. (ILSI 2000 text)

An expression of the risks associated with two (or more) actions leading to the same goal; may be expressed quantitatively (a ratio of 1.5) or qualitatively (one risk greater than another risk). Any comparison among the risks of two or more hazards with respect to a common scale. (RAIS 2004, SRA 2004)
RELATED TERMS:cumulative risk assessment

conceptual model

A diagram or written description of the predicted key relationships between the stressor(s) and the assessment endpoint(s) for a risk assessment. (EPA 1997b)

A conceptual model in problem formulation is a written description and visual representation of predicted relationships between ecological entities and the stressors to which they may be exposed. (EPA 1998a)

A written description and/or a visual representation of actual or predicted relationships between humans or ecological entities and the chemicals or other stressors to which they may be exposed. (EPA 2004)

The conceptual model describes a series of working hypotheses of how the stressor might affect ecological entities. The conceptual model also describes the ecosystem potentially at risk, the relationship between measures of effect and assessment endpoints, and exposure scenarios. (CENR 1999)

A visual presentation of the proposed structure of the risk assessment model showing data needs, model outputs, and logical flow of the calculations. (FDA 2002)

A conceptual model depicts the purpose, defines the scope and scale, determines appropriate variables and identifies data needed for risk assessment. It can also serve as a preliminary or exploratory risk assessment. (ILSI 2000 text)

cumulative risk

The combined risk from aggregate exposures to multiple agents or stressors. (EPA 2004)

cumulative risk assessment

An analysis, characterization, and possible quantification of the combined risks to health or the environment from multiple agents or stressors. (EPA 2004)

Consideration of the total ecological risk from multiple stressors to a given eco-zone. (EPA 2005b)

(cumulative ecological risk assessment) A process that involves consideration of the aggregate ecological risk to the target entity caused by the accumulation of risk from multiple stressors. (EPA 1998a)

data integrity

Refers to security (i.e., the protection of information from unauthorized access or revision) to ensure that the information is not compromised through corruption or falsification. Data integrity is one of the constituents of data quality. (EPA 2004)

data objectivity

A characteristic indicating whether information is being presented in an accurate, clear, complete, and unbiased manner, and as a matter of substance, is accurate, reliable, and unbiased. Data objectivity is one of the constituents of data quality. (EPA 2004)

data quality

The encompassing term regarding the quality of information used for analysis and/or dissemination. Utility, objectivity, and integrity are constituents of data quality. (EPA 2004)

data quality objective (ACRONYM: DQO)

Qualitative or quantitative statement derived from the DQO process that clarify study objectives, define the appropriate type of data, and specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality and quantity of data needed to support the decisions. (EPA 2004)

Qualitative and quantitative statements of the overall level of uncertainty that a decision-maker will accept in results or decisions based on environmental data. They provide the statistical framework for planning and managing environmental data operations consistent with user’s needs. (EPA 2005b)

Expectation or goal regarding the precision and accuracy of measurements, inference from data regarding distributions for inputs, and prediction of the model. (FAO/WHO 2003b)

data quality objectives process

A systematic planning tool to facilitate the planning of environmental data collection activities. Data quality objectives are the qualitative and quantitative outputs from the DQO Process. (EPA 2004)

data utility

Refers to the usefulness of the information to the intended users. Data utility is one of the constituents of data quality. (EPA 2004)

effect

Change in the state or dynamics of an organism, system or (sub) population caused by the exposure to an agent. (IPCS/OECD 2004)

A biological change caused by an exposure. (MERREA 2005)

The change in the average or expected value of a given response due to the change of a given factor. The change of the given factor is usually from the lowest to the highest value of those tried experimentally, and the units of the effect are usually in the same units as the response. (NIST/SEMATECH 2005b)

A biological change caused by an exposure. (RAIS 2004, SRA 2004)

effect assessment

Combination of analysis and inference of possible consequences of the exposure to a particular agent based on knowledge of the dose-effect relationship associated with that agent in a specific target organism, system or (sub) population. (IPCS/OECD 2004)

endpoint

An observable or measurable biological event or chemical concentration (e.g., metabolite concentration in a target tissue) used as an index of an effect of a chemical exposure. (EPA 2003)

(Assessment endpoint) An explicit expression of the environmental value that is to be protected, operationally defined by an ecological entity and its attributes. For example, salmon are valued ecological entities; reproduction and age class structure are some of their important attributes. Together “salmon reproduction and age class structure” form an assessment endpoint. (EPA 1998a)
RELATED TERMS: outcome

expert judgment

Opinion of an authoritative person on a particular subject. (IPCS/OECD 2004)

Judgment involves a reasoned formation of opinions. An expert is someone with special knowledge or experience in a particular problem domain. Expert judgment is documented and can be explained to satisfy outside scrutiny. (FAO/WHO 2003b)
RELATED TERMS:best professional judgment

extra risk (ACRONYM: ER)

A calculation of risk of adverse effects which adjusts for background incidence rates of the same effects, by estimating risk at dose d only among the fraction of the population not expected to respond to the secondary (background) causes: ER = [P(d)-P(0)/1-P(0)]. For example, if the background rate (P(0)) = 0.8 and the response rate at dose d, P(d) = 0.9, then ER = (0.9 - 0.8)/(1-0.8) = 0.1/0.2 = 0.5. That is, at dose d, an additional 10% of the population is expected to respond adversely. But since only 20% of the population was expected to be free of adverse effects without the exposure of interest, this 10% represents 50% of the population that would otherwise have been unharmed by this exposure. (EPA 2003)

farm-to-table

Includes all steps involved in the production, storage, handling, distribution and preparation of a food product. (FAO/WHO 2003a)

fomite

An inanimate object which, when contaminated with a viable pathogen (bacterium, virus, etc.) can transfer the pathogen to a host. (CancerWeb 2005)

Articles that convey infection to others because they have been touched. (MERREA 2005)

An inanimate object that can be the source of an infection. (Queensland Health 2005)

Objects, such as clothing, towels, and utensils that possibly harbor a disease agent and are capable of transmitting it; usually used in the plural. (Stedman 2005)

food safety objective

The maximum frequency and/or concentration of a (microbiological) hazard in a food at the time of consumption that provides the appropriate level of health protection (ALOP). Example of FSO: 100 Listeria monocytogenes per gram of ready-to-eat food. (CAC 2002)

gray literature

Research reports that are not found in traditional peer-reviewed publications; for example: government agency monographs, symposium proceedings, and unpublished company reports. (NLM/NICHSR 2004)

hazard

A potential source of harm. (EPA 2003)

In a general sense, “hazard”is anything that has a potential to cause harm. In risk assessment, the likelihood of experiencing a noncancer health effect is called hazard (not risk). (EPA 2004)

(a) Potential for radiation, a chemical or other pollutant to cause human illness or injury.
(b) In the pesticide program, the inherent toxicity of a compound. Hazard identification of a given substances is an informed judgment based on verifiable toxicity data from animal models or human studies. (EPA 2005b)

A source of potential harm from past, current, or future exposures. (ATSDR 2004)

A biological, chemical, or physical agent in, or condition of, food with the potential to cause an adverse health effect. (CAC 1999)

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. A microbiological hazard is a hazard arising from bacteria, viruses, yeasts, molds and algae, parasitic protozoa and helminths, and their toxins or metabolites. (CAC 2002)

A biological, chemical or physical agent that has the potential to cause harm or loss. (CRCWQT 2002)

A biological, chemical or physical agent in, or condition of, food with the potential to cause harm. (FAO/WHO 2003a)

Biological, chemical or physical agents with the potential to cause an adverse health effect. (FDA 2002)

Inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub) population is exposed to that agent. (IPCS/OECD 2004)

A biological agent with the potential to cause an adverse health effect. (KIWA 2004)

A thing or action that can cause adverse effects (e.g., a human pathogen, a plant pest, an animal disease agent, the introduction of a specific commodity or product). In the OMAF framework, the term “hazard” is used to imply the cause of an adverse event and not the negative consequences. When referring to the negative consequences of a causal hazard, we encourage the use of terms such as negative outcome, consequence, or impact. (OMAF 1997)

A condition or physical situation with a potential for an undesirable consequence, such as harm to life or limb. (RAIS 2004, SRA 2004)

The definitions for hazard are in general agreement even though some are more limiting in scope than others.

hazard analysis critical control point system (ACRONYM: HACCP)

A systematic methodology to control hazards in a process by applying a two-part technique: first, an analysis that identifies hazards and their severity and likelihood of occurrence; and second, identification of critical points where the hazards may be controlled, and the monitoring criteria to ensure that controls are working effectively. CRCWQT 2002

The hazard analysis critical control point system (HACCP) is a scientific and systematic way of enhancing the safety of foods from primary production to final consumption through the identification and evaluation of specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. (FAO/WHO 2003a)
RELATED TERMS:control point

hazard assessment

The process of determining whether exposure to an agent can cause an increase in the incidence of a particular adverse health effect (e.g., cancer, birth defect) and whether the adverse health effect is likely to occur in humans. (EPA 2003)

Evaluating the effects of a stressor or determining a margin of safety for an organism by comparing the concentration which causes toxic effects with an estimate of exposure to the organism. (EPA 2005b)

A process designed to determine the possible adverse effects of an agent or situation to which an organism, system or (sub) population could be exposed. The process includes hazard identification and hazard characterization. The process focuses on the hazard in contrast to risk assessment where exposure assessment is a distinct additional step. (IPCS/OECD 2004)

An analysis and evaluation of the physical, chemical and biological properties of the hazard. (RAIS 2004, SRA 2004)

hazard characterization

A description of the potential adverse health effects attributable to a specific environmental agent, the mechanisms by which agents exert their toxic effects, and the associated dose, route, duration, and timing of exposure. (EPA 2003)

The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and/or their toxins. (CAC 1999)

The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable. (CAC 2003, FAO/WHO 2003b)

The qualitative or quantitative evaluation of the nature of the adverse effects associated with biological, chemical, and physical agents. (FDA 2002)

The qualitative and, wherever possible, quantitative description of the inherent properties of an agent or situation having the potential to cause adverse effects. This should, where possible, include a dose-response assessment and its attendant uncertainties. Hazard Characterization is the second stage in the process of Hazard Assessment, and the second step in Risk Assessment. (IPCS/OECD 2004)
RELATED TERMS: dose-effect relationship, effect assessment, dose-response relationship, concentration-effect relationship

hazard evaluation

A component of risk evaluation that involves gathering and evaluating data on the types of health injuries or diseases that may be produced by a chemical and on the conditions of exposure under which such health effects are produced. (EPA 2005b)

hazard identification

The process of determining whether exposure to an agent can cause a particular adverse health effect (e.g., cancer, birth defect) and whether the adverse health effect is likely to occur in humans at environmentally relevant doses. (EPA 2004)

Determining if a chemical or a microbe can cause adverse health effects in humans and what those effects might be. (EPA 2005b)

The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods. (CAC 1999, CAC 2003, FAO/WHO 2003b)

The identification of known or potential health effects associated with a particular agent. (FDA 2002)

The identification of the type and nature of adverse effects that an agent has as inherent capacity to cause in an organism, system or (sub) population. Hazard identification is the first stage in hazard assessment and the first step in the process of Risk Assessment. (IPCS/OECD 2004)

The identification of microbiological biological agents capable of causing adverse health effects and which may be present in water. (KIWA 2004)

The determination of whether a particular substance (e.g., chemical, microbiological, or physical element) or particular activity (skiing, climbing a ladder, etc.) is or is not causally linked to particular health, safety, environmental or ecological effects. Hazard identification is a qualitative description based on factors such as kind and quality of data on humans or laboratory animals, the availability of information from other studies (e.g., similarity to other chemicals, viruses or physical hazards) and the weight of the evidence from all of these data sources. (NYS 1998)

The process of determining whether exposure to an agent can cause an increase in the incidence of a health condition. (RAIS 2004, SRA 2004)

hazards analysis

Procedures used to (1) identify potential sources of release of hazardous materials from fixed facilities or transportation accidents; (2) determine the vulnerability of a geographical area to a release of hazardous materials; and (3) compare hazards to determine which present greater or lesser risks to a community. (EPA 2005b, RAIS 2004)

host characterization

Evaluation of the characteristics of a potentially exposed human population that may influence susceptibility to a particular pathogen. (ILSI 2000)

host pathogen profile

human exposure evaluation

Describing the nature and size of the population exposed to a substance and the magnitude and duration of their exposure. (EPA 2005b)

input

That which is put in or taken in, or which is operated on or utilized by any process or system (either material or abstract), e.g., the information that is put into a model. (FAO/WHO 2003b)

iterative process

The risk assessment process is not linear, but fluid and dynamic. During any of the three phases of risk assessment, problem formulation, analysis, and risk characterization, other phases might be revisited and refined. (ILSI 2000 text)

methods

A systematic procedure or mode of inquiry used in microbial risk assessment. (ILSI 2001)Note: methods are also used in in a number of other microbiological contexts such as specific analytical processes, protocols for conducting scientific procedures, and for various disciplinary approaches in microbiology.

multipathway assessment

An assessment that considers more than one exposure pathway. For example, evaluation of exposure through both inhalation and ingestion would be a multipathway assessment. Another example would be evaluation of ingestion of contaminated soil and ingestion of contaminated food. (EPA 2004)
RELATED TERMS: multipathway exposure, multipathway risk

population

An aggregate of individuals of a species within a specified location in space and time. (EPA 1998a)

A group of interbreeding organisms occupying a particular space; the number of humans or other living creatures in a designated area. (EPA 2005b)

A group or number of people living within a specified area or sharing similar characteristics (such as occupation or age). (ATSDR 2004)

The total number of inhabitants of a given area or country. In sampling, the population may refer to the units from which the sample is drawn, not necessarily the total population of people. (CDC 2005)

All the inhabitants of a given country or area considered together; the number of inhabitants of a given country or area. Sampling: the whole collection of units from which a sample may be drawn; not necessarily a population of persons; the units may be institutions, records, or events. The sample is intended to give results that are representative of the whole population. (Last 1983)

All the inhabitants of a given country or area considered together; the number of inhabitants of a given country or area. (MERREA 2005)

A population is any entire collection of people, animals, plants or things from which one may collect data. It is the entire group one is interested in, which one wishes to describe or draw conclusions about. In order to make any generalizations about a population, a sample, that is meant to be representative of the population, is often studied. For each population there are many possible samples. A sample statistic gives information about a corresponding population parameter. For example, the sample mean for a set of data would give information about the overall population mean. It is important that the investigator carefully and completely defines the population before collecting the sample, including a description of the members to be included. (STEPS 1997)
RELATED TERMS: parameter; contrast withsample

preliminary assessment

The process of collecting and reviewing available information about a known or suspected waste site or release. (EPA 2005b)

probabilistic risk analysis

Calculation and expression of health risks using multiple risk descriptors to provide the likelihood of various risk levels. Probabilistic risk results approximate a full range of possible outcomes and the likelihood of each, which often is presented as a frequency distribution graph, thus allowing uncertainty or variability to be expressed quantitatively. (EPA 2004)

Probabilistic analysis - Analysis in which distributions are assigned to represent variability or uncertainty in quantities. The form of the output of a probabilistic analysis is likewise a distribution. (FAO/WHO 2003b)
RELATED TERMS:probabilistic risk assessment

probabilistic risk assessment

problem formulation

In ecological risk assessment, the initial stage of a risk assessment where the purpose of the assessment is articulated, assessment endpoints and a conceptual model are developed, and a plan for analyzing and characterizing risk is determined. (EPA 2004)

In microbial assessment, a systematic planning step that identifies the goals, breadth, and focus of the microbial risk assessment, the regulatory and policy context of the assessment, and the major factors that will need to be addressed for the assessment. (ILSI 2000)
RELATED TERMS:planning and scoping

problem statement

A statement of the perceived problem to be studied by the risk assessment. Problem statements often also include statements about how the problem is going to be studied. (EPA 2004)

qualitative data

Observations or information characterized by measurement on a categorical scale, i.e., a dichotomous or nominal scale, or, if the categories are ordered, an ordinal scale. Examples are sex, hair color, death or survival, and nationality. (Last 1983)

qualitative risk assessment

A risk assessment based on data which, while forming an inadequate basis for numerical risk estimations, nonetheless, when conditioned by prior expert knowledge and identification of attendant uncertainties permits risk ranking or separation into descriptive categories of risk. (CAC 1999, FAO/WHO 2003b)

Risk assessment that is based on qualitative data or giving a qualitative result. The results are often stated in an estimated range, such as “there is a moderate to high risk of a certain outcome occurring.” (FDA 2001)

quantitative risk assessment

A risk assessment that provides numerical expressions of risk and indication of the attendant uncertainties. (EC 1995)

Risk assessment that uses modeling to determine the probability(s) of what can go wrong, how likely it is to happen, and how severe is the health impact. The results are stated in numerical terms, such as “there is a 42% probability that one illness may occur from eating a serving of X food with a certain health outcome.” (FDA 2001)

refined method

This method is intended to provide accurate exposure and risk using appropriately rigorous and scientifically credible methods. The purpose of such methods, models or techniques is to produce an accurate and precise estimate of exposure or risk, or both, consistent with data quality objectives or best practice, or both. (FAO/WHO 2003b)

risk

In the context of human health, the probability of adverse effects resulting from exposure to an environmental agent or mixture of agents. (EPA 2003)

In the context of human health, the probability of injury, disease, or death from exposure to a chemical agent or a mixture of chemicals. In quantitative terms, risk is expressed in values ranging from zero (representing the certainty that harm will not occur) to one (representing the certainty that harm will occur). (EPA 2004)

A measure of the probability that damage to life, health, property, and/or the environment will occur as a result of a given hazard. (EPA 2005b)

A measure of the chance that damage to life, health, property, or the environment will occur. (EPA 2005e)

The probability that something will cause injury or harm. (ATSDR 2004)

A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. (CAC 1999, 2003, FAO/WHO 2003b)

A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. A microbiological risk is a risk arising from the presence in food of bacteria, viruses, yeasts, molds and algae, parasitic protozoa and helminths, and their toxins or metabolites. (CAC 2002)

The probability that an event will occur, e.g., that an individual will become ill or die within a stated period of time or age. (CDC 2005)

The probability of a specified hazard causing harm. (CRCWQT 2002)

The likelihood of the occurrence and the magnitude of the consequences of exposure to a hazard on human health. (FDA 2002)

The product of the likelihood of the occurrence and the magnitude of the consequences of exposure to a pathogen on human health. (ILSI 2000)

The probability of an adverse effect in an organism, system or (sub)population caused under specified circumstances by exposure to an agent. (IPCS/OECD 2004)

The likelihood of occurrence of an adverse health effect consequent to a hazard in drinking water. (KIWA 2004)

The possibility of an adverse outcome and the likelihood and probability of its occurrence. (NYS 1998)

The probability that an individual will develop disease (or experience an event) in a specified period of time. Estimated by the cumulative incidence. (NZ 2002)

The likelihood of the occurrence and the magnitude of the consequences of an adverse event; a measure of the probability of harm and the severity of impact of a hazard. In the OMAF framework the term “risk” is always used to imply elements of probability and impact. We discourage the use of the term “risk” to imply only the probability component of risk. When referring to the probability component of risk we encourage the use of terms such as probability, likelihood, or frequency. (OMAF 1997)

The product of: impact of severity (consequence) and impact of likelihood (probability). Specifically for carcinogenic effects, risk is estimated as the incremental probability of an individual developing cancer over a lifetime as a result of exposure to a potential carcinogen. Specifically for noncarcinogenic (systemic) effects, risk is not expressed as a probability but rather is evaluated by comparing an exposure level over a period of time to a reference dose derived for a similar exposure period. (RAIS 2004)

The potential for realization of unwanted, adverse consequences to human life, health, property, or the environment; estimation of risk is usually based on the expected value of the conditional probability of the event occurring times the consequence of the event given that it has occurred. (SRA 2004)

The probability of an adverse event occurring. (USDA 2004)
RELATED TERMS: hazardThe ILSI and the Codex definitions are similar in that theyrecognize the relationship between the probability and the magnitude of an outcome in determining risk; however, ILSI characterizes a risk as neutral, while Codex limits the health effects to negative ones (“adverse” and “severity”). ILSI and Codex definitions also differ in that ILSI does not limit the vehicle of exposure to food, as Codex doe, although both organizations limit the causal event to a “pathogen” (generally, but not always, used to indicate a microbe).

risk analysis

A process for controlling situations where an organism, system or (sub) population could be exposed to a hazard. The risk analysis process consists of three components: risk assessment, risk management and risk communication. (IPCS/OECD 2004)

A detailed examination including risk assessment, risk evaluation, and risk management alternatives, performed to understand the nature of unwanted, negative consequences to human life, health, property, or the environment; an analytical process to provide information regarding undesirable events; the process of quantification of the probabilities and expected consequences for identified risks. (MERREA 2005, RAIS 2004, SRA 2004)

The process that includes risk assessment, risk management, and risk communication. (OMAF 1997)

risk assessment

In the context of human health, the evaluation of scientific information on the hazardous properties of environmental agents (hazard characterization), the dose-response relationship (dose-response assessment), and the extent of human exposure to those agents (exposure assessment). The product of the risk assessment is a statement regarding the probability that populations or individuals so exposed will be harmed and to what degree (risk characterization). (EPA 2003)

For air toxics, the scientific activity of evaluating the toxic properties of a chemical and the conditions of human or ecological exposure to it in order both to ascertain the likelihood that exposed humans or ecological receptors will be adversely affected, and to characterize the nature of the effects they may experience. (EPA 2004)

Qualitative and quantitative evaluation of the risk posed to human health and/or the environment by the actual or potential presence and/or use of specific pollutants.(EPA 2005b)

A methodology used to examine all possible risks involved with a particular product or organism. Risk assessment can be divided into four parts: identification of hazards; dose response (how much exposure causes particular problems (i.e., cancer, convulsions, death); exposure assessment (determining how much exposure will be received by people during particular activities); and risk characterization (determining a probability that a risk will occur). (EPA 2005e)

The scientific evaluation of known or potential adverse health effects resulting from human exposure to hazards. The process consists of the following steps: hazard identification, exposure assessment, hazard characterization (dose-response), and risk characterization. (FDA 2002)

The process of identifying and measuring the risk resulting from a specific use or occurrence of a chemical. Risk assessment takes into account the possible harmful effects on people of using the chemical in the way that is proposed and all the possible routes of exposure. (FSA 2005)

When referring to a microbial risk assessment, a process that evaluates the likelihood of human health effects occurring after exposure to a pathogenic microorganism or to a medium in which pathogens exist. (ILSI 2000)

A process intended to calculate or estimate the risk to a given target organism, system or (sub)population, including the identification of attendant uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system. The risk assessment process includes four steps: hazard identification, hazard characterisation (related term: dose-response assessment), exposure assessment, and risk characterization. It is the first component in a risk analysis process. (IPCS/OECD 2004)

A systematic approach to organizing and analyzing data, scientific knowledge, and other information to identify possible adverse human health or environmental effects which may occur because of exposure to an agent (chemical, microbiological, or physical substance) or an activity (skiing, climbing a ladder, etc.). It also estimates the likelihood of the effect occurring under specified conditions. A risk assessment generally has four steps: hazard identification, dose-response assessment, exposure assessment, and risk characterization. (NYS 1998)

The process of identifying a hazard and characterizing the risk presented by that hazard, in qualitative or quantitative terms. (OMAF 1997)

The process of establishing information regarding acceptable levels of a risk and/or levels of risk for an individual, group, society, or the environment. (RAIS 2004, SRA 2004)

risk assessment policy

Elaboration of guidelines for the choice of options and associated judgments as well as for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained. (CAC 2002)

Documented guidelines on the choice of options and associated judgments for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained. (CAC 2003)

risk assessment work plan

A document that outlines the specific methods to be used to assess risk, and the protocol for presenting risk results. The risk assessment work plan may consist of one document or the compilation of several work plans that, together, constitute the overall risk assessment work plan. (EPA 2004)

risk assessor

The person or group of people responsible for conducting a qualitative and quantitative evaluation of the risk posed to human health and/or the environment by environmental pollutants. (EPA 2004)

Member of team of interdisciplinary group of professionals, responsible for conducting the risk assessment. Includes individuals knowledgeable and experienced in the risk assessment process, provides specific technical expertise, mathematical modeler. (FDA 2002)

risk characterization

Integrates exposure and stressor-response to evaluate the likelihood of adverse ecological effects associated with exposure to a stressor. (EPA 1998a)

The integration of information on hazard, exposure, and dose-response to provide an estimate of the likelihood that any of the identified adverse effects will occur in exposed people. (EPA 2003)

The last phase of the risk assessment process in which the information from the toxicity and exposure assessment steps are integrated and an overall conclusion about risk is synthesized that is complete, informative and useful for decision-makers. In all cases, major issues and uncertainty and variability associated with determining the nature and extent of the risk should be identified and discussed. The risk characterization should be prepared in a manner that is clear, transparent, reasonable, and consistent. (EPA 2004)

The last phase of the risk assessment process that estimates the potential for adverse health or ecological effects to occur from exposure to a stressor and evaluates the uncertainty involved. (EPA 2005b)

The process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization, and exposure assessment. (CAC 1999, 2002, 2003; FAO/WHO 2003b)

The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment. (FAO/WHO 2003a)

Integration of hazard identification, hazard characterization and exposure assessment into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainties. (FDA 2002)

In a microbial risk assessment, estimation of the likelihood of adverse human health effects occurring as a result of a defined exposure to a microbial contaminant or medium. (ILSI 2000)

The qualitative and, wherever possible, quantitative determination, including attendant uncertainties, of the probability of occurrence of known and potential adverse effects of an agent in a given organism, system or (sub)population, under defined exposure conditions. Risk characterization is the fourth step in the risk assessment process. (IPCS/OECD 2004)

The qualitative and quantitative estimation, including attendant uncertainties of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization, and exposure assessment. (KIWA 2004)

The description of the nature and the magnitude of the health, safety, or environmental risk, including attendant uncertainties. Often, comparisons will be made to everyday risk occurrences (death from a car accident, being struck by lightening, etc.) to help characterize the risk and make it more understandable to the general public. (NYS 1998)

The process within risk assessment, of estimating the probability of harm and the severity of impact of an identified hazard, and describing attendant uncertainty. (OMAF 1997)

This last step in the risk assessment process characterizes the potential for adverse health effects and evaluates the uncertainty involved. (RAIS 2004)

There is agreement that the term risk characterization should refer to the final step of the risk assessment process. In some cases, some of the more specific requirements of risk characterization are spelled out. For example, transparency is a specific requirement mentioned in the EPA Air Toxics Risk Assessment Library. Transparency is not specifically mentioned in the other definitions, but other frameworks for risk assessment include a general requirement for transparency. The EPA-ILSI Framework (ILSI 2000) and the EPA Risk Characterization Handbook (EPA 100-B-00-002) include many risk management concepts. The Codex framework (CAC 1999) specifically excludes risk management from risk characterization.

risk communication

The exchange of information about health or environmental risks among risk assessors and managers, the general public, news media, and other stakeholders. (EPA 2004)

The exchange of information about health or environmental risks among risk assessors and managers, the general public, news media, interest groups, etc. (EPA 2005b, RAIS 2004)

The process of exchanging information about levels or significance of health or environmental risk. (EPA 2005e)

The exchange of information to increase understanding of health risks. (ATSDR 2004)

The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk related factors and risk perception among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. (CAC 2002, 2003, FAO/WHO 2003b)

Risk estimation describes the types and magnitude of effects anticipated from exposure to the microbe or medium and can be qualitative or quantitative depending on the data and methods used. (ILSI 2000text)

Quantification of the probability, including attendant uncertainties, that specific adverse effects will occur in an organism, system or (sub)population due to actual or predicted exposure. (IPCS/OECD 2004)

The scientific determination of the characteristics of risks, usually in as quantitative a way as possible. These include the magnitude, spatial scale, duration, and intensity of adverse consequences and their associated probabilities as well as a description of the cause and effect links. (RAIS 2004, SRA 2004)

risk evaluation

Establishment of a qualitative or quantitative relationship between risks and benefits of exposure to an agent, involving the complex process of determining the significance of the identified hazards and estimated risks to the system concerned or affected by the exposure, as well as the significance of the benefits brought about by the agent. It is an element of risk management. Risk evaluation is synonymous with risk-benefit evaluation. (IPCS/OECD 2004)

A component of risk assessment in which judgments are made about the significance and acceptability of risk. (MERREA 2004, RAIS 2004, SRA 2004)

risk factor

A characteristic (e.g., race, sex, age, obesity) or variable (e.g., smoking, exposure) associated with increased chance of toxic effects. Some standard risk factors used in general risk assessment calculations include average breathing rates, average weight, and average human life span. (EPA 2005e)

An aspect of personal behavior or lifestyle, an environmental exposure, or an inborn or inherited characteristic that is associated with an increased occurrence of disease or other health-related event or condition. (CDC 2005)

risk identification

Recognizing that a hazard exists and trying to define its characteristics. Often risks exist and are even measured for some time before their adverse consequences are recognized. In other cases, risk identification is a deliberate procedure to review, and it is hoped, anticipate possible hazards. (RAIS 2004, SRA 2004)

risk management

In the context of human health, a decision making process that accounts for political, social, economic and engineering implications together with risk-related information in order to develop, analyze and compare management options and select the appropriate managerial response to a potential chronic health hazard. (EPA 2003)

The decision-making process that uses the results of risk assessment to produce a decision about environmental action. Risk management includes consideration of technical, scientific, social, economic, and political information. (EPA 2004)

The process of evaluating and selecting alternative regulatory and non-regulatory responses to risk. The selection process necessarily requires the consideration of legal, economic, and behavioral factors. (EPA 2005b, RAIS 2004)

The process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. (Control in this case is defined as prevention, elimination, or reduction of hazards and/or minimization of risks.) (CAC 1999, USDA 2004)

The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment when available and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and if needed, selecting appropriate prevention and control options. This process can be managed at the national, regional or international level. (CAC 2002)

The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options. (CAC 2003, FAO/WHO 2003b)

The systematic evaluation of the water supply system, the identification of hazards and hazardous events, the assessment of risks, and the development and implementation of preventive strategies to manage the risks. (CRCWQT 2002)

The process of weighing policy alternatives in the light of results of risk assessment, and, if required, selecting and implementing appropriate control options, including regulatory measures. (FAO/WHO 2003a)

The process of weighing policy alternatives in light of results or risk assessment, and, if required, selecting and implementing appropriate control options, including regulatory measures. (FDA 2002)

The process of integrating the results of a risk assessment with other information to make decisions about the need for, method of, and extent of risk reduction. Policy considerations and statutory requirements can dictate the extent to which risk information is used in decision-making and the extent to which other factors-such as technical feasibility, cost, and offsetting benefits-play a role. (NYS 1998)

risk manager

The person or group responsible for evaluating and selecting alternative regulatory and non-regulatory responses to risk. (EPA 2004)

The representative of government at a national level or regional level or representative of international organization at the international level who has the responsibility of risk management. (CAC 2002)

A decision maker; individuals or group responsible for taking actions to control, reduce, or mitigate an identified hazard. (FDA 2002)

risk-benefit analysis

Determining and weighing the relative risks and benefits of taking a certain action. It includes determining who receives the risks and benefits. (Navy 2002)

safe

Condition of exposure under which there is a practical certainty that no harm will result to exposed individuals. (EPA 2005b)

safety

Practical certainty that adverse effects will not result from exposure to an agent under defined circumstances. It is the reciprocal of risk. (IPCS/OECD 2004)

A judgment of the acceptability of risk (a measure of the probability of an adverse outcome and its severity) associated with using a technology in a given situation, e.g., for a patient with a particular health problem, by a clinician with certain training, or in a specified treatment setting. (NLM/NICHSR 2004)

Relative protection from adverse consequences. (RAIS 2004, SRA 2004)

safety factor

Composite (reductive) factor by which an observed or estimated no-observed-adverse effect level (NOAEL) is divided to arrive at a criterion or standard that is considered safe or without appreciable risk. (IPCS/OECD 2004)
RELATED TERMS: assessment factor, uncertainty factor

safety limits

Limits set by expert committees, for all approved pesticides, of the level of exposure that will not harm people’s health. (FSA 2005)

source

An entity or action that releases a stressor to the environment (or imposes a stressor on the environment). (EPA 1998a)

A place where pollutants are emitted, for example, a chimney stack. (RAIS 2004, SRA 2004)

The origin of an agent for the purposes of an exposure assessment. (IPCS 2004)

stakeholder

Any organization, governmental entity, or individual that has a stake in or may be impacted by a given approach to environmental regulation, pollution prevention, energy conservation, etc. (EPA 2005b)

A person, group, or community who has an interest in activities at a hazardous waste site. (ATSDR 2004)

Any individual, group or organization that may affect, be affected by, or perceive itself to be affected by the risk or risk management activities. (CAC 2002)

stepwise approach

A stepwise approach includes a preliminary qualitative assessment of health and exposure before a quantitative risk assessment is pursued. The stepwise approach is used to prioritize resources, define the scope and to determine if adequate information is available for quantitative risk assessment. It is a feature of problem formulation. (ILSI 2000 text)

surrogate

Something that serves as a substitute. In risk analysis, surrogates are often used when data on the item of interest (a chemical, an industry, an exposure, etc.) is lacking. As an example, underground mining of coal and hardrock minerals can be used as a surrogate for underground oil shale mining. (RAIS 2004, SRA 2004)
RELATED TERMS: indicator

surrogate data

Data from studies of test organisms or a test substance that are used to estimate the characteristics or effects on another organism or substance. (EPA 2005b)

Substitute data or measurements on one quantity used to estimate analogous or corresponding values for another quantity. (FAO/WHO 2003b)

tiered analysis

An analysis arranged in layers/steps. Risk assessments/analyses are often conducted in consecutive layers/steps that begin with a reliance on conservative assumptions and little data (resulting in less certain, but generally conservative answers) and move to more study area specific data and less reliance on assumptions (resulting in more realistic answers). The level of effort and resources also increases with the development of more realistic data. (EPA 2004)

tools of microbial risk assessment

Techniques for conducting microbial risk assessment, which can be classified into three groups: qualitative, semiquantitative, and quantitative. (ILSI 2000)

transparency

Conducting a risk assessment in such a manner that all of the scientific analyses, uncertainties, assumptions, and science policies which underlie the decisions made throughout the risk assessment are clearly stated (i.e., made readily apparent). (EPA 2004)

For risk assessment to be transparent, methods, and assumptions should be clearly stated and understandable to the intended audience, so that the audience is able to evaluate the adequacy of the data and methods. (ILSI 2000 text)

The criteria by which adequate transparency is judged should include the intended audience because transparency for other risk assessors in the field is quite different than transparency designed for the general public. The purpose for the transparency may or may not be stated and can range from general review of the approach and assumptions to detailed information that would be required if the model or input data needed to be updated or replicated.

transparent

Characteristics of a process where the rationale, the logic of development, constraints, assumptions, value judgments, decisions, limitations and uncertainties of the expressed determination are fully and systematically stated, documented, and accessible for review. (CAC 1999, FAO/WHO 2003b)

water quality

A description of the chemical, physical and biological characteristics of water for a particular purpose. (CRCWQT 2002)